Study design

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Recalcitrant chronic plaque psoriasis

Intervention

Forty patients with recalcitrant psoriasis vulgaris were treated with indigo naturalis ointment and ointment vehicles were applied daily to either of two bilaterally symmetrical plaques for 12 weeks. Every two weeks, the investigators evaluate the treated plaques. (As of 10/04/07 the following sentence should be disregarded: the patients and investigators were blinded as to the content of the two bottles).

Intervention type

Drug

Phase

Not Applicable

Drug names

Indigo naturalis ointment

Primary outcome measures

Clinical and laboratory assessments were done at baseline and every two weeks thereafter until 12 weeks after the start therapy. The changes in Erythema, Scaling, Indurations (ESI) and and bilateral plaque areas are recorded from the beginning to end of the treatments. Erythema (redness), scaling and indurations (thickening), are scored on a 0 to 8 scale (where 0 = none and 8 = very severe); the sum of these scores for each target lesion is the ESI score. The bilateral plaque area is rated from of 0% to 100% (0% = clearance and 100% = baseline).

Secondary outcome measures

Investigators will take biopsies from each treated lesion and analysis the immunohistochemical stains for markers of proliferation, differentiation and inflammation at the end of treatment.

Overall trial start date

01/05/2004

Overall trial end date

30/04/2005

Reason abandoned

Eligibility

Participant inclusion criteria

1. Participants with bilateral symmetric, chronic plaque-type psoriasis2. Participants who have a history of plaque psoriasis for a minimum of two years3. Participants who have a history of resistance to at least two topical treatments (e.g. corticosteroid and vitamin D3 analogues)4. Participants who have good general health and normal full blood picture, renal, and liver function in tests done before starting the study5. Participants of childbearing age who agree to continue using birth control measures for the duration of the study6. Males and females between 18 and 75 years

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

40

Participant exclusion criteria

1. Chronic plaque psoriasis involving more than 60% of the body surface2. Pustular or generalised erythrodermic psoriasis3. Use of medications, which affect psoriasis during the study (e.g. systemic therapy including retinoids, methotrexate, cyclosporine, or corticosteroid and non-corticosteroid topical therapy, including vitamin D analogues, tazarotene, tacrolimus) 4. Systemic therapy for psoriasis within 30 days of baseline5. Ultra-Violet (UV) light therapy within 21 days of baseline6. Topical therapy within 14 days of baseline7. Participants that test positive for Human Immunodeficiency Virus (HIV), hepatitis B surface antigen, or hepatitis C8. Participants that have a current history of alcohol or drug abuse9. Participants that have a history of hepatitis10. Participants that have a clinically significant laboratory abnormality11. Participants that have a history of sensitivity to Chinese herbs, olive oil, yellow wax and Vaseline12. Female participants who are lactating, pregnant or planning to become pregnant13. Participants that have participated in another clinical trial in the last 30 days14. Participants who are unwilling to comply with study protocol15. Any other conditions, which in the opinion of the investigators could compromise the study